High Flow Nasal Therapy Versus Noninvasive Ventilation in COPD Exacerbation

COPD Exacerbation Clinical Trial

Official title:

High Flow Nasal Therapy Versus Noninvasive Ventilation in Mild to Moderate Acute Hypercapnic Respiratory Failure: A Non-inferiority Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03370666
• Other study ID #: 07/17
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: April 2020
• Source: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Randomized multicenter non-inferiority trial comparing High flow nasal therapy (HFNT) versus Noninvasive ventilation (NIV) in patients with chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure.

Description:

The interventions will be delivered in Emergency Departments or Intensive Care Units.

The intervention under investigation will be High flow nasal therapy. Investigators will deliver HFNT to enrolled patients using any available device able to produce it. The flow will be initially set at 60 liters per minute and temperature at 37° C. The target will be an oxygen saturation (SpO2) of 88-92%. In case of patient not tolerating these settings, flow and temperature will be titrated to the maximum tolerated level. The intervention will last until one of the following conditions: 1) physician in charge decide to interrupt HFNT and start NIV because the patient shows signs of persisting worsening respiratory failure; 2) physician in charge decide to interrupt HFNT and perform endotracheal intubation and invasive mechanical ventilation because patient shows one or more of these conditions: respiratory arrest, respiratory pauses with loss of consciousness, psychomotor agitation making nursing care impossible, heart rate < 50 with loss of alertness, hemodynamic instability with systolic arterial blood pressure <70 mmHg, development of conditions requiring intubation either to protect the airway or to manage copious tracheal secretions, inability to tolerate the devices; 3) clinical improvement defined as all these conditions: normal mental status, hemodynamic stability, respiratory rate below 25 per minute, absence of activation of accessory respiratory muscles and paradoxical abdominal motion, no dyspnea arterial pH > 7.35, Arterial partial pressure of carbon dioxide (PaCO2) < 70 mmHg and Arterial partial pressure of oxygen (PaO2) > 55 mmHg with an inspired oxygen fraction (FiO2) < 0.35.

In case of temporary interruption of the intervention for any cause, patients should receive oxygen supplementation with Venturi mask with a target of SpO2 88-92%.The comparator will be non invasive ventilation (NIV). NIV must be delivered by full or oronasal mask. The ventilator settings will be decided according to the usual practice: maximal tolerated inspiratory pressure to obtain a measured or estimated expired tidal volume of 6-8 mL·kg-1 of body weight and a positive end expiratory pressure (PEEP) between 3 and 5 cmH2O. An interface rotational strategy will be allowed among only different types of masks.

The intervention will last until one of the following conditions: 1) physician in charge decide to interrupt NIV and perform endotracheal intubation and invasive mechanical ventilation because patient shows one or more of these conditions: respiratory arrest, respiratory pauses with loss of consciousness, psychomotor agitation making nursing care impossible, heart rate < 50 with loss of alertness, hemodynamic instability with systolic arterial blood pressure <70 mmHg, development of conditions requiring intubation either to protect the airway or to manage copious tracheal secretions, inability to tolerate the devices; 2) clinical improvement defined as all these conditions: normal mental status, hemodynamic stability, respiratory rate below 25 per minute, absence of activation of accessory respiratory muscles and paradoxical abdominal motion, no dyspnoea arterial pH > 7.35, Arterial partial pressure of carbon dioxide (PaCO2) < 70 mmHg and Arterial partial pressure of oxygen (PaO2) > 55 mmHg with an inspired oxygen fraction (FiO2) < 0.35.

In case of temporary interruption of NIV for any cause, patients should receive oxygen supplementation with Venturi mask with a target of SpO2 88-92%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 15, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Presence of chronic obstructive pulmonary disease (COPD) and acute hypercapnic respiratory failure;

• 7.25 < pH < 7.35;

• Arterial Partial pressure of carbon dioxide (PaCO2) equal or greater than 55 mmHg;

• Age > 18 years/old

Exclusion Criteria:

• Invasive mechanical ventilation in the last 60 days

• Use of any form of noninvasive ventilation or high flow oxygen through nasal cannula (HFNT) prior to study enrollment after the onset of acute hypercapnic respiratory failure (AHRF);

• Noninvasive home care ventilation;

• Unstable clinical condition (need for vasopressors for >24 h, acute coronary syndrome or life-threatening arrhythmias);

• Refusal of treatment;

• Agitation (RASS >= +2) or non-cooperation (Kelly Matthay >=5);

• Failure of more than two organs;

• Cardiac arrest;

• Respiratory arrest requiring tracheal intubation;

• Recent trauma or burns of the neck and face;

• Pregnancy;

• Refusal of consent;

• Inclusion in other research protocols.

Related Conditions & MeSH terms

• COPD Exacerbation
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• HFNT
High flow nasal therapy
• NIV
Noninvasive ventilation

Locations

Country	Name	City	State
Italy	Ospedale S. Donato	Arezzo
Italy	Ospedale Sant'Orsola Malpighi. Università Alma Mater	Bologna
Italy	A.O.U. Policlinico-Vittorio Emanuele, Università degli Studi di Catania	Catania
Italy	Azienda Ospedaliera Universitaria Mater Domini	Catanzaro
Italy	University Hospital of Modena, Pneumology Unit and Center for Rare Lung Diseases, Department of Medical and Surgical Sciences, University of Modena and Reggio Emilia	Modena
Italy	Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone. Università degli Studi di Palermo	Palermo
Italy	IRCCS Maugeri	Pavia
Italy	Azienda Ospedaliera di Perugia	Perugia
Italy	Ospedale Molinette	Torino
Italy	Azienda Sanitaria Universitaria Integrata di Udine	Udine

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo	Azienda Ospedaliera Policlinico "Mater Domini"

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Respiratory rate		2 and 6 hours after randomization
Other	Discontinuation of the interventions	The inability of the patient to continue the treatment while there was still an indication for ventilatory support	At 6 hours after randomization
Other	Overall discomfort related to the interface		At 6 hours after randomization
Other	Presence of side effects	I.e., complaining for noise or too high temperature of flow, claustrophobia, gastric distension, vomiting, sweating, tightness	At 6 hours after randomization
Other	Rate of treatment failure	defined as the presence of one or more of the following: arterial partial pressure of carbon dioxide (PaCO2) reduction, no change or reduction < 10 mmHg from baseline, worsening or no improvement in dyspnoea, respiratory rate > 30 breaths per minute, use of accessory respiratory muscles or paradoxical abdominal movement	At 6 hours after randomization
Other	Rate of endotracheal intubation	Number of patients requiring endotracheal intubation	At 6 hours after randomization
Primary	Arterial partial pressure of carbon dioxide (PaCO2)		2 hours after randomization
Secondary	Dyspnea evaluated with Borg dyspnea scale	Borg dyspnea scale: this is a 12-point validated scale that rates patient's difficulty in breathing. It starts at number 0 where breathing causes no difficulty at all and progresses through number 10 where breathing difficulty is maximal	2 and 6 hours after randomization
Secondary	Arterial partial pressure of carbon dioxide (PaCO2)		6 hours after randomization